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Treats established nonunion acquired secondary to trauma, excluding vertebrae and flat bones, where defect width is < half bone width.
Use is contraindicated for individuals with synovial pseudarthrosis.
Safety/effectiveness not established for individuals lacking skeletal maturity. Pacemakers may be affected. Long-term human effects unknown.
Nonunion fractures with gaps >1cm not evaluated. Safety during pregnancy/nursing not established. Not for patients with conditions precluding compliance.
Rare instances of reversible minor discomfort reported: cumbersome, tingling, pain, minor skin rash.
Proven safe and effective in clinical studies with an 80% success rate in patients averaging 3+ hours of daily treatment.
Explains how to turn the device on/off, use the backlight button, and what the LCD displays, including status and time.
Details how to charge the lithium-ion battery pack using the provided Orthofix charging system. Recharging is recommended after daily treatment.
Describes U-shaped models for placement on limbs (tibia, femur, radius), worn over clothing, casts, or fixation devices.
Instructions for applying the Model 3313 on the collarbone (clavicle), ensuring the control unit is visible and strap is secured.
Instructions for applying Model 3313 on a limb (e.g., thigh/femur) using the short strap, ensuring it's centered and secure.
Instructions for applying Models 3314L/3314R on the left or right shoulder (proximal humerus), securing the strap correctly.
Instructions for applying Model 3315 on the hip (proximal femur), securing the elastic strap around the body.
Lists classifications like internally powered equipment, Type BF applied part, IPX0 enclosure rating, and intermittent operation mode.
Advice for air travel: check device with luggage, avoid screening devices. Carry manual for identification.
Specifies storage temperature range (-10°C to 45°C), operating temperature range (+5°C to 40°C), and relative humidity (up to 95%).
Instructions for disposing of the device, which contains lithium batteries. Do not incinerate. Use collection facilities for waste electrical equipment.
Provides contact numbers for questions or assistance. States there are no user-serviceable parts and to notify the manufacturer for servicing.
General| Brand | Orthofix |
|---|---|
| Model | Physio-Stim |
| Category | Medical Equipment |
| Language | English |
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